Use of Combination Empagliflozin/Linagliptin or Dapagliflozin/Saxagliptin vs Empagliflozin or Dapagliflozin Alone, Subclinical Inflammation of the Genito-urinary Tract and Risk of Infections.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from Baseline of total bacterial load
研究概览
简要总结
In this observational study, 60 subjects with type 2 diabetes (T2D) and eligible, as per good clinical practice, for therapy with SGLT-2 inhibitor, will be randomized to receive a SGLT-2 inhibitor or a fixed dose combination of SGLT-2 inhibitor with a DPP4-inihibitor for 12 weeks. Measures will be performed at baseline and after 12 weeks of treatment, as per good clinical practice.
详细描述
The day of the study patients undergo a routine clinical evaluation. Whole blood samples will be collected from an antecubital vein to assess serum/plasma aliquots of 200 μl each (frozen at -80°C until required for quantitation) for evaluation of biochemical parameters (fasting glucose, HbA1c, lipid profile, serum creatinine, uric acid, electrolytes, liver function enzymes, albumin).
A mid-stream first urine in the morning sample will be collected into a sterile container. 50 ml of urine will be immediately transferred into a sterile falcon and centrifugated at 4500 rpm for 10 min. After removal of the supernatant and addition of 10 ml of PBS or sterile physiological solution, the sample will be further centrifugated at 4500 rpm for 10 min. The supernatant will be removed and the pellet stored in a falcon at -80°C.
Genomic DNA will be extracted throw Qiamp DNA mini kit (QIAGEN) and quantified using spectrophotometric assay.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes diagnosis
- •Hb1Ac ≥ 7% and ≤ 9%
排除标准
- •Hb1Ac > 9%
- •current treatment with an SGLT2i or a DPP4i drugs, or in the prior 4 week
- •irritating and/or obstructive urinary or genital symptoms
- •menstrual cycle for women
- •current antibiotic treatment or in the prior 4 weeks
- •anatomical or functional abnormalities of the urinary tract (e.g. incontinence, neurological bladder, bladder prolapse).
研究组 & 干预措施
SGLT2 and DPP-4 inhibitors
Patients undergoing SGLT2i and DPP4i.
干预措施: Empagliflozin / Linagliptin or Dapagliflozin/Saxagliptin Pill (Drug)
SGLT2 inhibitors only
Patients undergoing SGLT2i alone.
干预措施: Empagliflozin or Dapagliflozin Pill (Drug)
结局指标
主要结局
Change from Baseline of total bacterial load
时间窗: Each patients will be analyzed at baseline and after 12 weeks
Absolute quantification of total bacterial load in the original sample using real-Time quantitative PCR
Change from Baseline in metagenomic analysis based on rRNA 16S gene
时间窗: Each patients will be analyzed at baseline and after 12 weeks
Metagenomic analysis based on rRNA 16S gene will be performed by Novogene on Illumina platform (Hong Kong, China)
次要结局
- Total cholesterol(baseline and 12 week)
- HDL cholesterol(baseline and 12 week)
- Renal function(baseline and 12 week)
- Glycated Haemoglobin(baseline and 12 week)
- Fasting glucose(baseline and 12 week)
- Albumin excretion(baseline and 12 week)
- Triglycerides(baseline and 12 week)
研究者
Anna Solini
Associate Professor
University of Pisa